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Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT) (SYNSEQ)

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Electrophysiological Study

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is indicated or recommended for CRT-P or CRT-D device according to current applicable ESC/AHA guidelines
Subject is in sinus rhythm
Subject receives optimal heart failure oral medical therapy
Subject is willing to sign the informed consent form
Subject is 18 years or older

Exclusion Criteria:

Subject has permanent atrial fibrillation/flutter or tachycardia
Subject has pure right bundle branch block (= no additional left ventricular conduction delays)
Subject has left bundle branch block and QRS-duration of > 150 ms and no sign of myocardial scar indicated by late gadolinium enhancement MRI
Subject experienced recent myocardial infarction, within 40 days prior to enrollment
Subject underwent valve surgery, within 90 days prior to enrollment
Subject is post heart transplantation, or is actively listed on the transplantation list
Subject is implanted with a left ventricular assist device
Subject has severe renal disease (up to physicians discretion)
Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
Subject has complex and uncorrected congenital heart disease
Subject has a mechanical heart valve
Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager

Sites / Locations

Klinika Choroby Wieńcowej
Medical University of Silesia, Silesian Center for Heart Disease,
Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH)
Východoslovenský ústav srdcových a cievnych chorôb, a.s. (VUSCH)
Hospital Universitari I Politècnic La Fe
Skåne University Hospital
Queen Elizabeth Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrophysiological Study

Arm Description

Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.

Outcomes

Primary Outcome Measures

Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec)

LV dP/dt max is a measurement of the initial velocity of myocardial contraction and is derivative of the LV-pressure. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as ([median dP/dt max during pacing On] - (median baseline dP/dt max during pacing Off])/[median dP/dt max during pacing Off]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.

Secondary Outcome Measures

Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure

Measured by invasive arterial blood line connected to a sensitive membrane displacement sensor. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected.The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as ([median pressure during pacing On] - (median pressure during pacing Off])/[median pressure during pacing Off]. Correlation will be summarized over all pacing configurations and time points since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration or per time point. The general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation.

Correlation Between Percentage Change LV dP/dt Max and Percentage Change Non-Invasive Blood Pressure

Acquired through finger volume clamp

Correlation Between Percentage Change LV dP/dt Max and Q-LV Ratio

Derived from intra-cardiac leads (invasive) and surface electrodes (non-invasive) respectively. The Q-LV interval is defined as the time from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV electrogram (EGM) during a cardiac cycle. The Q-LV ratio will be calculated as Q-LV/QRS duration. Correlation will be summarized over all pacing configurations since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration. The general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation between % change LV dP/dt max and Q-LV ratio.

Correlation Between Percentage Change LV dP/dt Max and % Change QRS Width

Derived from surface electrodes (non-invasive). The percentage change is determined as ([QRS width during pacing On] - (QRS width during pacing Off])/[QRS width during pacing Off]. The correlation between % change LV dP/dt max and % change QRS width will be summarized over all pacing configurations since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration or per time point. The general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used to determine the correlation.

Full Information

NCT ID

NCT02914457

First Posted

June 8, 2016

Last Updated

September 3, 2020

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

1. Study Identification

Unique Protocol Identification Number

NCT02914457

Brief Title

Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)

Acronym

SYNSEQ

Official Title

Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for CRT

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

November 7, 2016 (Actual)

Primary Completion Date

April 20, 2018 (Actual)

Study Completion Date

April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by MultiSpot LV pacing (either simultaneously or sequentially) in comparison to the response achieved by the current (standard) BiV pacing configuration in patients indicated/recommended for cardiac resynchronization therapy.

Detailed Description

The following pacing configurations will be evaluated. Biventricular pacing (BiV): Pacing will be performed on one LV electrode pair, (at 3 different longitudinal locations), and on the tip of the RV-lead. In total, three different pacing BiV settings will be evaluated. Configuration 1: RV + LV lateral Apex, Configuration 2: RV + LV lateral Mid, Configuration 3: RV + LV lateral Base (Reference: Standard CRT) MultiSpot simultaneous LV-ventricular pacing (MultiSpot-SYN): Pacing will be performed on 3 electrodes on the LV wall, placed at different longitudinal locations, and on the tip of the RV-lead simultaneously. Configuration 4: RV + LV lateral Apex + LV lateral Mid + LV lateral Base MultiSpot sequential LV-ventricular pacing (MultiSpot-SEQ): 3 electrodes on the LV wall will be paced sequentially. The RV electrode will be paced simultaneously with last paced LV electrode.The timing-sequence and the amount of spots will depend on the electrical delays measured during the experiments. Configuration 5: LV lateral Apex => LV lateral Mid => LV lateral Base + RV

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electrophysiological Study

Arm Type

Experimental

Arm Description

Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.

Intervention Type

Procedure

Intervention Name(s)

Electrophysiological Study

Intervention Description

Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.

Primary Outcome Measure Information:

Title

Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec)

Description

Time Frame